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Talk to a SpecialistTalk to a SpecialistMonarch PCM, LLC, a drug manufacturer in Fort Worth, Texas, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in its products being deemed adulterated. The company manufactured several unapproved new drugs including Hydroquinone USP 4% Skin Bleaching Cream, Sodium Sulfacetamide products, and Selenium Sulfide 2.25% Shampoo without proper FDA approval and failed to properly list certain products with the FDA as required. The inspection from June to August 2021 identified significant violations in the company's manufacturing methods, facilities, and controls that rendered its drug products non-compliant with federal regulations.